Conference call to be held November 16, 2017
at 4:30 p.m. Eastern time
PAVmed Inc. (Nasdaq: PAVM, PAVMW), a highly
differentiated, multiproduct medical device company, today
announced financial results for the three and nine months ended
September 30, 2017 and provided a business update.
Management Commentary
“During this quarter and in recent weeks, PAVmed has continued
its inexorable march towards important developmental, regulatory
and commercialization milestones,” said Lishan Aklog, M.D.,
PAVmed’s Chairman and Chief Executive Officer.
“Last month we filed a pre-submission to the U.S. Food and Drug
Administration (FDA), as we now seek a de novo classification for
our PortIO™ Intraosseous Infusion System. PortIO is an implantable
vascular access device designed to provide long-term access to the
bone marrow cavity, for the delivery of medications, fluids or
other substances, eliminating many of the shortcomings of existing
devices, especially in patients with poor veins. The pre-submission
provides our proposal for limited additional testing to support a
longer, seven-day indication which will cover the use of the device
in most inpatient scenarios. It includes a request for an in-person
meeting with the FDA next month. If we are successful in obtaining
de novo classification clearance, we plan to proceed with
commercialization of the device while using it as a predicate for
longer, expanded indications through the 510(k) pathway. Our
initial commercialization strategy will focus on independent
distributors targeting key opinion leaders and early adopters.”
Dr. Aklog added, “Our CarpX™ device designed to treat carpal
tunnel syndrome through a minimally invasive approach, remains the
most commercially promising and clinically exciting lead product in
our pipeline. We have weathered some last-minute delays and are
poised to complete testing and submit this game-changing device to
the FDA for 510(k) clearance later this month. Upon successful
regulatory clearance, we anticipate an aggressive commercialization
strategy using well-established independent sales channels
targeting the appropriate physician specialties. We believe that
CarpX will provide an attractive alternative for the 600,000
patients a year who undergo traditional carpal tunnel surgery in
the U.S. in terms of invasiveness, pain, recovery time, and cost
effectiveness, as well as the vast number of patients who choose to
avoid surgery and suffer in silence.”
“Our final lead product, DisappEAR, is progressing well along
its development path,” continued Dr. Aklog. “DisappEAR is our
resorbable, anti-microbial pediatric ear tube which utilizes a
propriety aqueous silk technology licensed from Tufts University
and two Harvard teaching hospitals. It is designed to provide a
more efficacious and patient-friendly alternative to traditional
plastic ear tubes that are inserted in over one million children
annually. We expect that DisappEAR will be ready for FDA submission
in the second half of 2018.”
“Finally, we strengthened our balance sheet during the third
quarter, raising $5.5 million from the sale of senior secured
notes, warrants, and convertible preferred stock, providing us with
the resources to advance our lead products towards
commercialization.”
Financial Results
Research and development expenses for the three months ended
September 30, 2017 were $704,866. General and administrative
expenses for the three months ended September 30, 2017 were
$1,263,122.
PAVmed reported an operating loss for the three months ended
September 30, 2017 of $1,967,988 and a GAAP net loss of $5,129,318.
Included in the GAAP net loss were non-cash charges totaling
$2,799,188 related to a change in the fair value of Series A
warrant liability and a related change in fair value of a Series A
Convertible Preferred Stock conversion option embedded derivative
liability. Also included was a non-cash charge for stock-based
compensation expense of $272,301 and depreciation expense of
$1,802.
For the three months ended September 30, 2017, GAAP net loss
attributable to common stockholders was $5,370,313, or $0.40 per
common share. As illustrated below and for the purpose of helping
the reader to understand the effect of derivative accounting for
non-cash income and expenses on the Company’s financial results,
the Company reported a non-GAAP adjusted loss for the three months
ended September 30, 2017 of $1,693,885, or $0.13 per common
share.
Research and development expenses for the nine months ended
September 30, 2017 were $2,063,319. General and administrative
expenses for the nine months ended September 30, 2017 were
$4,082,366.
PAVmed reported an operating loss for the nine months ended
September 30, 2017 of $6,145,685 and a GAAP net loss of
$10,389,113. Included in the GAAP net loss were non-cash charges
totaling $3,881,286 related to the issuance of Series A Preferred
Stock Units, a change in the fair value of Series A warrant
liability and a related change in fair value of a Series A
Convertible Preferred stock conversion option embedded derivative
liability. Also included was a non-cash charge for stock-based
compensation expense of $799,281 and depreciation expense of
$5,307.
For the nine months ended September 30, 2017, GAAP net loss
attributable to common stockholders was $10,707,819, or $0.80 per
common share. The Company reported a non-GAAP adjusted loss for the
nine months ended September 30, 2017 of $5,341,097, or $0.40 per
common share, as illustrated below.
PAVmed had cash and cash equivalents of $3,111,456 as of
September 30, 2017, compared with $585,680 as of December 31,
2016.
The unaudited financial results for the three and nine months
ended September 30, 2017 as reported to the SEC on Form 10-Q can be
obtained at www.pavmed.com or www.sec.gov.
Non-GAAP Measures
To supplement our unaudited financial results presented in
accordance with U.S. generally accepted accounting principles
(GAAP) in our Quarterly Report on Form 10-Q, management provides
certain non-GAAP financial measures of the Company's financial
results. These non-GAAP financial measures include net loss before
interest, taxes, depreciation and amortization (EBITDA) and
non-GAAP Adjusted Loss, which further adjusts EBITDA for
stock-based compensation expense, loss on the issuance of the
Series A Preferred Stock Units, the change in fair value of the
Series A Warrant liability and the change in fair value of the
Series A Convertible Preferred Stock conversion option embedded
derivative liability. The foregoing non-GAAP financial measures of
EBITDA and non-GAAP Adjusted Loss are not recognized terms under
U.S. GAAP.
Non-GAAP financial measures are presented with the intent of
providing greater transparency to information used by us in our
financial performance analysis and operational decision-making. We
believe these non-GAAP financial measures provide meaningful
information to assist investors, shareholders and other readers of
our unaudited financial statements in making comparisons to our
historical financial results and analyzing the underlying
performance of our results of operations. These non-GAAP financial
measures are not intended to be, and should not be, a substitute
for, considered superior to, considered separately from or as an
alternative to, the most directly comparable GAAP financial
measures.
Non-GAAP financial measures are provided to enhance readers’
overall understanding of our current financial results and to
provide further information for comparative purposes. Management
believes the non-GAAP financial measures provide useful information
to management and investors by isolating certain expenses, gains
and losses that may not be indicative of our core operating results
and business outlook. Specifically, the non-GAAP financial measures
include non-GAAP adjusted loss and its presentation is intended to
help the reader understand the effect of the loss on the issuance
of the Series A Preferred Stock Units and the corresponding
derivative accounting for non-cash charges on financial
performance. In addition, management believes non-GAAP financial
measures enhance the comparability of results against prior
periods.
A reconciliation to the most directly comparable GAAP measure of
all non-GAAP financial measures included in this press release for
the three and nine months ended September 30, 2017 and 2016 is as
follows:
Three Months Ended September 30,
Nine Months Ended September 30,
2017
2016 2017 2016 Net loss per
common share, basic and diluted ($0.40) ($0.14) ($0.80) ($0.31)
Net loss attributable to common stockholders (5,370,313)
(1,928,722) (10,707,819) (3,940,337) Preferred Stock dividends
240,995 - $318,706
Net loss as reported (5,129,318)
(1,928,722) (10,389,113) (3,940,337) Adjustments: Depreciation
expense1 1,802 1,478 5,307 2,315 Interest expense, net 362,142 -
362,142 - Income tax (benefit) expense - - - -
EBITDA
(4,765,374) (1,927,244) (10,021,664) (3,938,022)
Other
non-cash expenses: Stock-based compensation expense2 272,301
322,985 799,281 499,628 Loss from issuance of Preferred Stock
Units3 - - 3,124,285 - Change in fair value of Series A Warrant
Liabiity3 2,215,671 - 680,851 -
Change in fair value of Series A Preferred
Stockconversion option embedded derivative liabiity3
583,517 - 76,150 -
Non-GAAP adjusted (loss) (1,693,885)
(1,604,259) (5,341,097) (3,438,394) Basic and Diluted shares
outstanding 13,332,629 13,310,000 13,331,585 12,855,714 Non-GAAP
adjusted (loss) income per share ($0.13) ($0.12) ($0.40) ($0.27) 1
Included in general and administrative expenses in
the financial statements 2
The three and nine months ended September
30, 2017 includes $241,401 and $707,588, respectively, of
stock-basedcompensation expense reported as general and
administrative expenses and $30,900 and $91,693,
respectively,reported as research and development expense. The
three and nine months ended September 30, 2016 includes$292,085 and
$447,233, respectively, of stock-based compensation expense
reported as general andadministrative expenses and $30,900 and
$52,396, respectively, reported as research and development
expense.
3 Included in other income and expenses in the financial
statements.
Conference Call and Webcast
The Company will hold a conference call and webcast on November
16, 2017 at 4:30 p.m. Eastern time. During this call, Dr. Aklog
will provide a business update, including an overview of the
Company’s near-term milestones and growth strategy. In addition,
Dennis McGrath, the Company’s Chief Financial Officer, will discuss
third quarter 2017 financial results.
To access the conference call, U.S.-based participants should
dial (888) 803-5993 and international participants should dial
(706) 634-5454. All participants should provide the following
passcode: 8082249. Individuals interested in listening to the live
conference call via the Internet may do so by visiting the
Company’s website at www.pavmed.com.
Following the conclusion of the conference call, a replay will
be available through November 22, 2017 and can be accessed by
dialing (855) 859-2056 from within the U.S., or (404) 537-3406 from
outside the U.S. All listeners should provide passcode: 8082249.
The webcast will be available for 90 days on the Company’s website
at www.pavmed.com.
About PAVmed
PAVmed Inc. is a highly differentiated, multiproduct medical
device company employing a unique business model designed to
advance products from concept to commercialization much more
rapidly and with significantly less capital than the typical
medical device company. This proprietary model enables PAVmed to
pursue an expanding pipeline strategy with a view to enhancing and
accelerating value creation. PAVmed’s diversified pipeline of
products address unmet clinical needs, have attractive regulatory
pathways and market opportunities and encompass a broad spectrum of
clinical areas including carpal tunnel syndrome (CarpX™),
interventional radiology (PortIO™ and NextCath™), pediatric ear
infections (DisappEAR™) medical infusions (NextFlo™ and NextCath™),
and tissue ablation and cardiovascular intervention (Caldus™). The
Company intends to further expand its pipeline through engagements
with clinician innovators and leading academic medical centers. For
further information, please visit www.pavmed.com.
Forward-Looking Statements
This press release includes forward-looking statements that
involve risks and uncertainties. Forward-looking statements are
statements that are not historical facts. Such forward-looking
statements, based upon the current beliefs and expectations of the
Company’s management, are subject to risks and uncertainties, which
could cause actual results to differ from the forward-looking
statements. Risks and uncertainties that may cause such differences
include, among other things, the uncertainties inherent in research
and development, including the cost and time required advance our
products to regulatory submission; whether regulatory authorities
will be satisfied with the design of and results from our
preclinical studies; whether and when our products are cleared by
regulatory authorities; market acceptance of our products once
cleared and commercialized; our ability to raise additional funding
and other competitive developments. PAVmed has not yet received
clearance from the FDA or other regulatory body to market any of
its products. New risks and uncertainties may arise from time to
time and are difficult to predict. All of these factors are
difficult or impossible to predict accurately and many of them are
beyond our control. For a further list and description of these and
other important risks and uncertainties that may affect our future
operations, see Part I, Item IA, “Risk Factors,” in our most recent
Annual Report on Form 10-K filed with the Securities and Exchange
Commission, as the same may be updated in Part II, Item 1A, “Risk
Factors” in any Quarterly Reports on Form 10-Q filed by us after
our most recent Annual Report. We disclaim any intention or
obligation to publicly update or revise any forward-looking
statement to reflect any change in our expectations or in events,
conditions, or circumstances on which those expectations may be
based, or that may affect the likelihood that actual results will
differ from those contained in the forward-looking statements.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171115005494/en/
PAVmed Inc.InvestorsLHA Investor
RelationsKim Sutton Golodetz, 212-838-3777kgolodetz@lhai.comorMediaRooneyPartnersMarion Janic,
212-223-0651mjanic@rooneyco.com
PAVmed (NASDAQ:PAVMW)
Historical Stock Chart
From Mar 2024 to Apr 2024
PAVmed (NASDAQ:PAVMW)
Historical Stock Chart
From Apr 2023 to Apr 2024